Teva Recalls Prednisolone Oral Solution for Failed Stability Specifications
Teva Pharmaceuticals USA is recalling specific lots of Prednisolone Oral Solution because they failed stability specifications.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which indicates the product is unlikely to cause adverse health consequences. The source text cites failed stability specifications without reporting any illnesses or injuries.
Plain-English summary
Teva Pharmaceuticals USA is recalling 49,089 bottles of Prednisolone Oral Solution USP, 15 mg/5mL, 240 mL bottles. The affected product is an alcohol-containing prescription liquid manufactured in Canada by Contract Pharmaceuticals Limited Canada for Teva Pharmaceuticals USA.
The recall was initiated because the product failed stability specifications. The affected lots are # 94358 (Exp. 05/17), # 94920A (Exp. 07/17), and # 97083A (Exp. 12/17). The product was distributed nationwide.
Consumers should check their medication for the NDC 0093-6118-87 and the lot numbers listed above. If the product matches these details, they should stop using it and contact their pharmacist or healthcare provider for guidance on disposal or replacement.
The recalled product
- Product
- PrednisoLONE Oral Solution USP, 15 mg/5mL, alcohol content: 5%(v/v) 240 mL bottle, Rx Only, Manufactured in Canada By: CONTRACT PHARMACEUTICALS LIMITED CANADA, Ontario, Canada, L5N 6L6, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC 0093-6118-87
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Oral Solution
- Hazard
- Affected units
- 49,089
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot # 94358
- Exp. 05/17 Lot # 94920A
- Exp. 07/17 Lot # 97083A
- Exp. 12/17
Distribution
Distributed nationwide across the United States.
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